What is the FIT-BRAIN Trial?
Multi-institutional Phase 2/3 Trial of Fresh Frozen Plasma (FFP) in Patients with Moderate to Severe Traumatic Brain Injury (TBI)” or “FFP In Traumatic BRain INjury (FIT-BRAIN) Trial” is a research study that will look at how plasma (the colorless fluid part of blood) given to traumatic brain injury patients soon after injury will affect the brain, and see if it will help in their injury recovery. This study uses an investigational treatment. “Investigational” means that plasma as a treatment for traumatic brain injury is under investigation and is not approved for this use in the United States by the Food and Drug Administration (FDA). For this study, people who have traumatic brain injuries will be randomly picked to get either usual care or usual care + FFP as part of their treatment at the hospital. Information from health records for both groups will also be collected as part of the study. Researchers will look at both groups of people and see if one group did better than the other.

Who will be included?
FIT-BRAIN Trial will enroll adults who are between 18 and 65 years old who are:

• Patients with a moderate to severe head injury, with a Glasgow Coma Scale (GCS) score between 3 and 12 (scale measures your eye, movement and verbal response)
• Patients with a brain bruise at least 8 millimeters in diameter

 Patients who meet any of the following criteria will be excluded:

1. Persons with a known history of adverse reaction to plasma products.
2. Persons with a known history of congestive heart failure, renal failure, liver failure, or severe respiratory dysfunction requiring home use of supplemental oxygen.
3. Persons who are currently incarcerated.
4. Persons with inadequate venous access.
5. Treatment cannot start within 1 hour of arrival at the hospital.
6. The time of injury is unknown.
7. Non-survivable injuries in the estimation of the attending trauma and/or neurosurgeon.
8. Interfacility transfers
9. Class 3 hemorrhagic shock
10. Persons with known “do not resuscitate” orders prior to randomization
11. Persons who refuse the administration of blood products
12. Persons with a research “opt out” bracelet
13. Persons who require FFP for any other indication (e.g., reversal of coagulopathy)

Where will the study take place?
The study will take place at Vanderbilt and at 7 other sites across the US.

Why Fresh Frozen Plasma (FFP)?
There is information that suggests FFP can reduce brain damage, swelling, and help with long term brain function. Some early evidence in people suggests that it could be a good treatment option.

How will FFP be given?
FFP will be given one time as an intravenous (into a vein) infusion, which will begin within an hour of arriving in the emergency department. The treatment will be given in addition to usual care. No care will be withheld because of the research trial.

What are the risks? Are there any benefits?
Plasma has been in wide use across the world for a variety of treatments, but its use has some risks.  Risks commonly associated with plasma transfusion include injury to the lungs, fluid overload, and allergic reactions. Some other risks include transmission of viruses and other pathogens (disease causing organisms), white blood cell-associated risks and red blood cell immune system responses. These risks have been shown to be very rare (< 1%).

Risks and discomforts from study procedures

• Blood draw: Pain, redness, soreness, bruising, or infection may occur at the needle stick site.
• ECG: To measure your heart rate an electrocardiogram (ECG) will be done. This is a test that records the electrical activity of the heart. Sticky patches will be fixed to your chest as you lie down. You will be asked to lie still.  The sticky pads used for the ECG may cause skin irritation.
• Confidentiality: Any time information is collected there is a potential risk for loss of confidentiality. Every effort will be made to keep your information confidential; however, this cannot be guaranteed. This research study involves the use of your identifiable, personal information and there is a chance that a loss of confidentiality could occur. The researchers have procedures in place to decrease the possibility of this happening.

Because this treatment is investigational, meaning non-FDA approved, there may be risks that we do not know about at this time. 

We are conducting this study because we anticipate that the benefits of getting FFP may include less injury than if you had not received plasma or an increased chance of survival. The additional study laboratory tests may provide information beneficial to you. The information that we obtain from this study may benefit others in the future and help us to provide more effective treatments for patients with traumatic brain injury in both the civilian and military populations. 

How are people enrolled in the study?
People who have traumatic brain injuries who are transported to a research site participating in the FIT-BRAIN Trial may be included in this study.

Normally, researchers must ask a person for their consent before they can be in a research study. Because traumatic brain injuries must be treated right away, there may not be time to get consent. Giving consent for medical research usually means reading information, talking with doctors and nurses, and having time to think about whether to join. A person with a traumatic brain injury is often not able to do these things. Sometimes researchers can talk to the patient’s family to ask for consent. However, in the emergency of a traumatic brain injury, the family is often not around or can’t be found before the injured person must be treated. This study could not be done without special permission to include people before getting consent. This permission is called Exception from Informed Consent, or EFIC. Once the enrolled person is better and can consent or their family arrives at the hospital, the researchers will ask for consent to continue with the study. For more information regarding EFIC, please visit: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM249673.pdf].

How do I opt out of the study?
You can opt-out of the study by contacting us using any of the methods below and letting us know that you do not want to participate. Please make sure to give us your name and contact information so that we can get in touch with you. We can provide you with a hypoallergenic silicone bracelet to wear that indicates that you should not be enrolled into the study. Please note that opting out of the study only means that you will not receive FFP as part of the study. Opting out will not prevent you from receiving normal care.

For questions or to learn more about this study, please call us at 1-888-244-8700, email us at fit-brain_trial@northwestern.edu, or complete the contact form below: